X-Gen Pharmaceuticals Inc.

FDA Drug Class III Terminated

Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC

April 2, 2024 X-Gen Pharmaceuticals Inc. 1283 vials units

FDA Drug Class III Terminated

Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted

April 2, 2024 X-Gen Pharmaceuticals Inc. 1332 vials units

FDA Drug Class II Terminated

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

March 19, 2021 X-Gen Pharmaceuticals Inc. 720 100-count (10x10 blister strips) units

FDA Drug Class III Terminated

Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X

October 11, 2019 X-Gen Pharmaceuticals Inc. 25120 vials units

FDA Drug Class III Terminated

Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.

March 29, 2019 X-Gen Pharmaceuticals Inc. 24,966 vials units

FDA Drug Class II Terminated

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

May 17, 2017 X-Gen Pharmaceuticals Inc. 9,816 bottles units

FDA Drug Class I Terminated

Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharma

February 8, 2017 X-Gen Pharmaceuticals Inc. 2593 cartons units

FDA Drug Class III Terminated

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.

July 17, 2014 X-Gen Pharmaceuticals Inc. 8,356 vials units